SIMEON MEDICAL GMBH & CO KG

Address(es)
  • In Grubenäcker 18
    Tuttlingen 78532
    Germany

Website Not available
Status

MEMBER

Acceptance date 2014-05-20

Further information

Stage

Country

Name

1

Denmark

LEGEND: Scope Limitations
  • RA : Audio amplifiers with audio power > 0,5 Watts excluded
  • RC : Apparatus with connection(s) to a cable distribution system excluded
  • RSH : Shredders excluded
  • RT : Apparatus with connection(s) to a telecommunication network excluded
  • RV : CRT (cathode ray tubes)/ picture tubes, plasma/LCD or other video apparatus excluded
  • ROUT : Equipment intended for installation outdoors excluded
  • RWPT : Wireless power transmitter excluded

Category

Name

Tests/Clauses

Acceptance Date

Responsible National Certification Body

MED

Accepted clauses:8.7.4.6 Measurement of the TOUCH CURRENT9.4.2 Stability and Transportability9.4.2.4.2 Mobile Equipment Force for Propulsion9.4.2.4.3 Mobile Equipment Over a Threshold9.4.3.1 Instability from Unwanted Lateral Movement (Including Sliding)9.4.3.2 Instability Excluding Transport9.7 Hydrostatic Pressure Test9.8.2 Tensile Safety Factor9.8.3.1 Mechanical Strength - Patient Support System9.8.3.2 Mechanical Strength - Foot Rests/Sitting9.8.4 Suspension System w/ Safety Devices Loading (60601-1 AM1 Only)15.3.5 Rough Handling
2019-11-21

MED

Accepted clauses:8.7.4.6 Measurement of the TOUCH CURRENT9.4.2 Stability and Transportability9.4.2.4.2 Mobile Equipment Force for Propulsion9.4.2.4.3 Mobile Equipment Over a Threshold9.4.3.1 Instability from Unwanted Lateral Movement (Including Sliding)9.4.3.2 Instability Excluding Transport9.7 Hydrostatic Pressure Test9.8.2 Tensile Safety Factor9.8.3.1 Mechanical Strength - Patient Support System9.8.3.2 Mechanical Strength - Foot Rests/Sitting9.8.4 Suspension System w/ Safety Devices Loading (60601-1 AM1 Only)15.3.5 Rough Handling
2019-11-21

MED

Accepted clauses:8.7.4.6 Measurement of the TOUCH CURRENT9.4.2 Stability and Transportability9.4.2.4.2 Mobile Equipment Force for Propulsion9.4.2.4.3 Mobile Equipment Over a Threshold9.4.3.1 Instability from Unwanted Lateral Movement (Including Sliding)9.4.3.2 Instability Excluding Transport9.7 Hydrostatic Pressure Test9.8.2 Tensile Safety Factor9.8.3.1 Mechanical Strength - Patient Support System9.8.3.2 Mechanical Strength - Foot Rests/Sitting9.8.4 Suspension System w/ Safety Devices Loading (60601-1 AM1 Only)15.3.5 Rough Handling
2023-06-15

MED

DETACHABLE HANDLE: (IEC 60601-2-41, Sub-Clause 201.9.2.101)Ease of motion and stability: (IEC 60601-2-41, Sub-Clause 201.9.4.2.2.101)Protective Means: (IEC 60601-2-41, Sub-Clause 201.9.5.1.101)ILLUMINANCE: (IEC 60601-2-41, Sub-Clause 201.10.5.102.1)LIGHT FIELD DIAMETER d10: (IEC 60601-2-41, Sub-Clause 201.10.5.102.2a)Diameter d50: (IEC 60601-2-41, Sub-Clause 201.10.5.102.2b)Remaining illuminance with one mask: (IEC 60601-2-41, Sub-Clause 201.10.5.102.3a)Remaining illuminance with two mask: (IEC 60601-2-41, Sub-Clause 201.10.5.102.3b)Remaining illuminance with cavity: (IEC 60601-2-41, Sub-Clause 201.10.5.102.3c)Remaining illuminance with cavity and one mask: (IEC 60601-2-41, Sub-Clause 201.10.5.102.3d )Remaining illuminance with cavity and two masks: (IEC 60601-2-41, Sub-Clause 201.10.5.102.3e)DEPTH OF ILLUMINATION: (IEC 60601-2-41, Sub-Clause 201.10.5.102.4)IR irradiance (IEC 60601-2-41, Sub-Clause 201.10.6.102)Ultraviolet radiation: (IEC 60601-2-41, Sub-Clause 201.10.7)UV hazard weighted irradiance (IEC 60601-2-41, Sub-Clause 201.10.7.102)UV-A irradiance (IEC 60601-2-41, Sub-Clause 201.10.7.103)Total irradiance (IEC 60601-2-41, Sub-Clause 201.10.101.1.3)Blue light hazard weighted irradiance (IEC 60601-2-41, Sub-Clause 201.10.101.1.5) Retinal thermal hazard weighted irradiance (IEC 60601-2-41, Sub-Clause 201.10.101.1.6)Blue light hazard weighted radiance (IEC 60601-2-41, Sub-Clause 201.10.101.2.3)Retinal thermal hazard weighted radiance (IEC 60601-2-41, Sub-Clause201.10.101.2.4)Maximum temperature during NORMAL USE: (IEC 60601-2-41, Sub-Clause 201.11.1.1)Interruption of the power supply/SUPPLY MAINS to ME EQUIPMENT: (IEC 60601-2-41, Sub-Clause 201.11.8.101)Spectral characteristics: (IEC 60601-2-41, Sub-Clause 201.12.1.102.2.2)Temperature rise in the lighted surface: (IEC 60601-2-41, Sub-Clause 201.12.1.102.3)Stability of the light source: (IEC 60601-2-41, Sub-Clause 201.12.1.101)Lamp failure: (IEC 60601-2-41, Sub-Clause 201.12.1.101)HAZARDOUS SITUATIONS for FAIL SAFE EQUIPMENT: (IEC 60601-2-41, Sub-Clause 201.13.1.101
2023-06-15

MED

DETACHABLE HANDLE: (IEC 60601-2-41, Sub-Clause 201.9.2.101)Ease of motion and stability: (IEC 60601-2-41, Sub-Clause 201.9.4.2.2.101)Protective Means: (IEC 60601-2-41, Sub-Clause 201.9.5.1.101)Ultraviolet radiation: (IEC 60601-2-41, Sub-Clause 201.10.7)Maximum temperature during NORMAL USE: (IEC 60601-2-41, Sub-Clause 201.11.1.1)Interruption of the power supply/SUPPLY MAINS to ME EQUIPMENT: (IEC 60601-2-41, Sub-Clause 201.11.8.101)CENTRAL ILLUMINANCE: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3a)LIGHT FIELD DIAMETER d10: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3b)Diameter d50: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3c)Remaining illuminance with one mask: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3d)Remaining illuminance with tube: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3e)Remaining illuminance with tube: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3f)Remaining illuminance with tube and one mask: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3g)Remaining illuminance with tube and two masks: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3h)DEPTH OF ILLUMINATION: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3i)Spectral characteristics: (IEC 60601-2-41, Sub-Clause 201.12.1.102.2.2)Temperature rise in the lighted surface: (IEC 60601-2-41, Sub-Clause 201.12.1.102.3)Stability of the light source: (IEC 60601-2-41, Sub-Clause 201.12.1.102.4a)Lamp failure: (IEC 60601-2-41, Sub-Clause 201.12.1.102.4b)HAZARDOUS SITUATIONS for FAIL SAFE EQUIPMENT: (IEC 60601-2-41, Sub-Clause 201.13.1.101)
2020-04-21

MED

DETACHABLE HANDLE: (IEC 60601-2-41, Sub-Clause 201.9.2.101)Ease of motion and stability: (IEC 60601-2-41, Sub-Clause 201.9.4.2.2.101)Protective Means: (IEC 60601-2-41, Sub-Clause 201.9.5.1.101)Ultraviolet radiation: (IEC 60601-2-41, Sub-Clause 201.10.7)Maximum temperature during NORMAL USE: (IEC 60601-2-41, Sub-Clause 201.11.1.1)Interruption of the power supply/SUPPLY MAINS to ME EQUIPMENT: (IEC 60601-2-41, Sub-Clause 201.11.8.101)CENTRAL ILLUMINANCE: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3a)LIGHT FIELD DIAMETER d10: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3b)Diameter d50: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3c)Remaining illuminance with one mask: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3d)Remaining illuminance with tube: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3e)Remaining illuminance with tube: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3f)Remaining illuminance with tube and one mask: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3g)Remaining illuminance with tube and two masks: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3h)DEPTH OF ILLUMINATION: (IEC 60601-2-41, Sub-Clause 201.12.1.102.1.3i)Spectral characteristics: (IEC 60601-2-41, Sub-Clause 201.12.1.102.2.2)Temperature rise in the lighted surface: (IEC 60601-2-41, Sub-Clause 201.12.1.102.3)Stability of the light source: (IEC 60601-2-41, Sub-Clause 201.12.1.102.4a)Lamp failure: (IEC 60601-2-41, Sub-Clause 201.12.1.102.4b)HAZARDOUS SITUATIONS for FAIL SAFE EQUIPMENT: (IEC 60601-2-41, Sub-Clause 201.13.1.101)
2020-04-21

MED

201.9.8.3.2 Static forces due to loading from persons
2019-11-21